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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Full-Montage Standard Electroencephalograph
510(k) Number K905435
Device Name UNIQUANT
Applicant
NEUROCONCEPTS, INC.
6510 SCHROEDER RD.
MADISON,  WI  53711
Applicant Contact DENNIS ROSCOE
Correspondent
NEUROCONCEPTS, INC.
6510 SCHROEDER RD.
MADISON,  WI  53711
Correspondent Contact DENNIS ROSCOE
Regulation Number882.1400
Classification Product Code
GWQ  
Date Received12/04/1990
Decision Date 07/22/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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